- Experience Needed:
- More than 20 years
- Career Level:
- Job Type:
- Full Time
- Education Level:
- Bachelor's Degree at least
About the Job
Quality Activities :
- Ensures that all manufacturing process is following strictly the GMP regulations, securing, in parallel, that it will be in line with the approved SOP.
- Authorizes the final release of the products.
- Prevents any incident, before occurrence, from happening that may alter the quality of the product which in return can cause product turning back or recall or even clients’ complains.
- Ensures that required documents are available when needed.
- Sets procedures that ensure the correct handling of materials and documents.
- Performs self-audits on a regular basis.
- Performs external-audits according to Annual Plan.
- Conducts training programs on a scheduled basis.
- Solves technical problems related to product quality.
- Ensures the appropriate filing and archiving of documents.
- Works with the manufacturing management improve procedures related to quality.
- Reviews and corrects or completes documents relative to quality technical documents.
- Secures the calibration of all reading devices, as well as, the calibration and validation of all equipment by inspecting them on a routine basis.
- Makes sure that no change in the production process or the acquirement of raw materials can take place in any field without taking the appropriate measures for validation and approval.
- Reviews and approves the batch records prepared by production & Q.A. department.
- Manages & supervises departmental employees, assigns work and special projects, monitors workload and productivity, evaluates performance and promotes staff training and development.
- Identifies the required technical training and cooperates closely with HR Manager on issues of training, development, vacation schedules and makes proposals for hiring, firing, promotions, bonus and salary increases.
- Coordinates with the departments of Production, Warehouse, Engineering and HR to achieve departmental and company objectives.
- Secures the compliance with the quality, environment, safety requirements according to national and international standard (ISO 9001, 14001).
- Identifies, records and updates the various aspects within the department and their impact on the environment.
- Participates in setting implementing and amending the environmental programs.
- Determines and identifies the emergency situations in the department.
- Ensures that the disposal of waste in the department is effected in line with the waste management policy.
- Carries out periodical environmental awareness sessions to the employees in the department.
- Approves all Product Quality related documents
- Assures the compliance of Methods of Analysis to the Registered Files.
- Assures the compliance of Products Specifications to the Registered Files.
- Assures the compliance of know how of Products with the Registered Files.
- Manages the preparation and performance of Process Validation Protocols, Cleaning Validation, and Machines / Utilities Qualifications in coordination with QC, Production, and Engineering
- Manages the preparation and performance of Computer Validation Protocols in coordination with IT and any related Department.
About this Company
Since its establishment in 1997, Global Napi Pharmaceuticals was self-committed to present the highest quality of medicines to the patients. A principle that challenged us to offer the competitive environment and do all the efforts to satisfy patients, employees, business...
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